In 1943, U.S. v. Dotterweich, the Supreme Court ruled that the responsible officials of a corporation, as well as the corporation itself, may be prosecuted for violations. It need not be proven that the officials intended, or even knew of, the violations.

Buffalo Pharmacal Company, and Joseph Dotterweich, its president and general manager were charged  with shipping in interstate commerce adulterated and misbranded drugs in violation of section 301 of the Federal Food, Drug, and Cosmetic Act.